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FDA 510(k)

PEDIATRIC URINARY CATHETER

K-Number: K060268 · 2006-02-24

ApplicantClay Kennard
Decision Date2006-02-24
Product CodeGBM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PEDIATRIC URINARY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Clay Kennard. It received FDA 510(k) clearance on 2006-02-24 under 510(k) number K060268. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEDIATRIC URINARY CATHETER?

PEDIATRIC URINARY CATHETER is a medical device that received FDA 510(k) clearance on 2006-02-24. The listed applicant is Clay Kennard. The 510(k) number is K060268.

When did PEDIATRIC URINARY CATHETER receive FDA 510(k) clearance?

PEDIATRIC URINARY CATHETER received FDA 510(k) clearance on 2006-02-24, under 510(k) number K060268.

Who is the listed applicant for PEDIATRIC URINARY CATHETER?

The FDA 510(k) record lists Clay Kennard as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PEDIATRIC URINARY CATHETER?

The FDA product code for PEDIATRIC URINARY CATHETER is GBM.

Related Clinical Trials

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Related Devices (Code: GBM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter CompactWell Lead Medical Co., Ltd.K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterConvatec LimitedK211436Intermittent Catheter (Not Finalized)Hollister IncorporatedK200820SpeediCath Compact SetColoplastK192904SpeediCath Compact SetColoplastK200142SpeediCath SoftColoplast

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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